Gastrectomy resection line guide device

Abstract

To provide a resection line guide device for gastrectomy, the device making it possible to clearly view and recognize a resection line under a laparoscope and being capable of being taken as a guide for volume of a stomach's part to be left.SOLUTION: A resection line guide device for gastrectomy comprises: a flexible tube 2 having a first passage and a second passage that are formed along a longer direction; and a balloon 3 that is provided coaxially around the tube on the tip side 2a of the tube and is expandable in a cylindrical shape. The tube has: a first hole 23a communicating with the first passage, on a tip 23 exposed on the tip side from the balloon; a suction connection part 4 that is provided on a base end side 2b of the tube and communicates with the first passage; a second hole formed to make the balloon's internal space communicate with the second passage; and an injection connection part 6 that is provided on the base end side and communicates with the second passage.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a resection line guide device for gastrectomy. [Background technology]

[0002] Recently, in the field of bariatric surgery, a gastrectomy device has been proposed that facilitates the performance of a sleeve gastrectomy procedure (see, for example, Patent Document 1).

[0003] Sleeve gastrectomy is a laparoscopic procedure in which the greater curvature of the stomach is removed and a sleeve-shaped gastric tube is formed to reduce the volume of the stomach, with the aim of reducing food intake in patients with morbid obesity.

[0004] The gastrectomy device described in Patent Document 1 comprises a tubular member that is inserted into the stomach through the esophagus, a balloon that is provided at the tip of the tubular member and positioned in the pylorus when expanded in the stomach, and an expansion source that injects fluid into the balloon to expand the balloon into a prolate spheroid (spheroid). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2015-93198 A Summary of the Invention [Problem to be solved by the invention]

[0006] With conventional gastrectomy devices, a balloon is provided at the tip of a tubular member so as to be placed in the pylorus, and surgery is performed to preserve the lesser curvature of the stomach using the position of the tubular member as a guide, making it difficult to provide a guide for the volume of the remaining stomach.

[0007] The objective of the present invention is to provide a resection line guide device for gastrectomy which, when performing sleeve gastrectomy, allows the resection line to be clearly visualized under laparoscopy, as compared to conventional devices, even when a thin-diameter tube that can be gently inserted into the stomach, and which can serve as a guide for the volume of the stomach to be left. [Means for solving the problem]

[0008] [1] A flexible tube having a length sufficient to reach the pylorus of the stomach from the mouth or nose and having a first passage and a second passage formed along the longitudinal direction; a balloon provided coaxially around the tube at the distal end side of the tube and capable of expanding into a cylindrical shape; The tube has a first hole formed in a tip portion exposed distally of the balloon and communicating with the first passage, a first connection portion formed in a base end of the tube and communicating with the first passage to which a suction device is connected, a second hole formed in a tip portion of the tube and communicating with the internal space of the balloon to the second passage, and a second connection portion formed in a base end of the tube and communicating with the second passage to which an injection device for injecting fluid into the balloon is connected. [2] The resection line guide device for gastrectomy described in [1], wherein the balloon has a length of 130 mm or more and 180 mm or less. [3] A resection line guide device for gastrectomy as described in [1] or [2], wherein the balloon expands into a cylindrical shape having an outer diameter of 12 mm or more and 16 mm or less when the fluid is injected. [4] A resection line guide device for gastrectomy described in any one of [1] to [3], wherein the balloon is formed, together with the tube, into a curved cylindrical shape having an inner circumferential surface with a radius of curvature of 50 mm or more and 200 mm or less when inflated. [5] A resection line guide device for gastrectomy described in any one of [1] to [4], wherein the balloon is configured such that the amount of fluid injected is proportional to the volume of the desired sleeve-shaped gastric tube. Effect of the Invention

[0009] According to the invention of claims 1 to 3, when performing sleeve gastrectomy, even if a thin-diameter tube that can be gently inserted into the stomach is used, the resection line can be clearly visualized under laparoscopy compared to conventional devices, and the resection line can be used as a guide for the volume of the stomach to be left. According to the invention of claim 4, the balloon can be easily made to conform to the lesser curvature of the stomach, compared to a configuration in which the balloon expands without curving when inflated. According to the invention of claim 5, by controlling the amount of fluid injected into the balloon, a sleeve-shaped gastric tube having a volume close to the target volume can be formed. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is an external view showing an example of a schematic configuration of a resection line guide device for gastrectomy according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a cross-sectional view taken along line AA in FIG. [Diagram 3] FIG. 3 is a cross-sectional view taken along line BB in FIG. [Figure 4] FIG. 4 is a cross-sectional view taken along line CC in FIG. [Diagram 5] FIG. 5 is a cross-sectional view of the stomach, showing a schematic state in which a balloon is inflated inside the stomach. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In each drawing, components having substantially the same functions are designated by the same reference numerals, and duplicated explanations will be omitted.

[0012] [Summary of the embodiment] The resection line guide device for gastrectomy in this embodiment comprises a flexible tube having a sufficient length to reach the pylorus of the stomach from the mouth or nose and having a first passage and a second passage formed along the longitudinal direction, and a cylindrically inflatable balloon provided coaxially around the tube on the tip side of the tube.

[0013] The tube has a first hole formed at a tip portion exposed distally of the balloon and communicating with the first passage, and a first connection portion communicating with the first passage and connected to a suction device is provided at a base end of the tube. The tube also has a second hole formed at a tip portion communicating with the balloon's internal space and the second passage, and a second connection portion communicating with the second passage and connected to an injection device that injects a fluid into the balloon is provided at a base end of the tube.

[0014] The tube preferably has a diameter (for example, 10 mm or less, desirably 5 mm or less) that allows gentle insertion into the stomach. In this specification, the term "expansion" in relation to the balloon means both the case where the balloon is made of a material having elasticity and the balloon material is stretched and expanded by injecting a fluid, and the case where the balloon is made of a material having almost no elasticity and the balloon is in a wrinkled and contracted state and the wrinkles are stretched and expanded by injecting a fluid.

[0015] [Embodiment Mode] FIG. 1 is an external view showing an example of a schematic configuration of a resection line guide device for gastrectomy according to an embodiment of the present invention.

[0016] This resection line guide device for gastrectomy (hereinafter abbreviated as "resection line guide device") 1 comprises a long tube 2 to be inserted inside the stomach, an inflatable and deflated balloon 3 provided coaxially around the tube 2 at the tip end side (also referred to as the distal end side) 2a of the tube 2, a suction connection part 4 provided at the base end side (also referred to as the proximal end side) 2b of the tube 2 and connected to a suction device that suctions the inside of the stomach, and an injection tube 5 and a fluid injection part 6 also provided at the base end side 2b of the tube 2 and connected to an injection device that injects a fluid into the balloon 3. The suction connection part 4 is an example of a first connection part. The fluid injection part 6 is an example of a second connection part.

[0017] The tube 2 has a tip portion 23 that is exposed about 20 to 30 mm on the tip side 2a from the balloon 3. The tip portion 23 includes an exposed portion 23a and a blocking portion 23b that blocks the opening of the tip side 2a of the exposed portion 23a. The tip portion 23 may be one in which the opening of the tip side 2a is sealed without providing the blocking portion 23b. The blocking portion 23b is formed from a material such as silicone, fluororesin, or polyurethane, and is joined to the exposed portion 23a by adhesion, welding, or the like. The exposed portion 23a is formed with a plurality of (for example, four) side holes 23c for reducing the pressure inside the stomach. The side holes 23c are an example of a first hole. The tip portion 23 may have an open discharge passage 20 as long as it seals only the fluid passage 21.

[0018] On the tube 2, scale marks 24 represented by straight lines are printed at positions 450 mm, 550 mm, 650 mm, and 750 mm away from the tip 23d of the tip portion 23. Note that each scale mark 24 may be printed with information indicating the distance from the tip 23d, such as the distance or a different mark for each distance (for example, the number of dots increases as the distance increases).

[0019] Both ends 3a of the balloon 3 are joined to the tube 2 by adhesion, welding, etc. The balloon 3 is shown in an inflated state in FIG.

[0020] (Tube structure) 2 is a cross-sectional view taken along line AA in FIG. 1, FIG. 3 is a cross-sectional view taken along line BB in FIG. 1, and FIG. 4 is a cross-sectional view taken along line CC in FIG.

[0021] The tube 2 has a length sufficient to reach the pylorus of the stomach from the mouth or nose (eg, about 1000 mm), and an outer diameter sufficient to be inserted transnasally into the stomach (eg, 4 mm or more and 6 mm or less).

[0022] The tube 2 is formed, for example, from a multi-lumen tube having a circular cross section, and has a discharge passage 20, a fluid passage 21, and a contrast medium sealing line 22 formed along the longitudinal direction. The discharge passage 20 is an example of a first passage. The fluid passage 21 is an example of a second passage.

[0023] The tube 2 is formed by extrusion molding from an elastic material such as silicone, fluororesin, polyurethane, etc., so as to have flexibility. The tube 2 may have an outer diameter that allows the gastrectomy device 1 to be orally inserted into the stomach.

[0024] 4, the openings on the tip side 2a of the tip portion 23 of the tube 2, i.e., the discharge passage 20, the fluid passage 21, and the contrast medium sealing line 22, are blocked by a blocking portion 23b. A side hole 23c, which is an example of a first hole, communicates with the discharge passage 20. Note that one first hole may be formed in the blocking portion 23b instead of the side hole 23c.

[0025] 4, the tip side 2a of the discharge passage 20 is closed by a closing portion 23b which is formed in a round shape, and the rear end side 2b communicates with a suction connection portion 4. By connecting a suction device to the suction connection portion 4 and using the suction device to suck in air inside the stomach through the side hole 23c, the discharge passage 20, and the suction connection portion 4, the pressure inside the stomach can be reduced and the stomach wall can be brought into close contact with the balloon 3.

[0026] As shown in FIG. 3 and FIG. 4, the fluid passage 21 has an injection hole 21a communicating with the internal space 3b of the balloon 3, and a base end side 2b connected to the fluid injection section 6 via an injection tube 5. The tip side 2a of the fluid passage 21 is closed by a blocking section 23b, and the base end side 2b is closed at the position of the injection tube 5. The fluid can be injected from an injection device into the internal space 3b of the balloon 3 via the fluid injection section 6, the injection tube 5, the fluid passage 21, and the injection hole 21a to expand the balloon 3 into a cylindrical shape. For example, water, saline, air, etc. can be used as the fluid to be injected into the balloon 3. In this embodiment, one injection hole 21a is formed at the center of the balloon 3 in the longitudinal direction, but multiple injection holes 21a may be formed along the longitudinal direction or along the longitudinal direction and circumferential direction. The injection hole 21a is an example of a second hole.

[0027] The contrast medium-filled line 22 is formed when the tube is molded, and is filled from the distal end side to the proximal end side, excluding the blocked portion. The contrast medium-filled line 22 may be X-rayed to confirm the position of the tube 2.

[0028] (Balloon structure) The balloon 3 is formed from an elastic material such as silicone, but may be formed by blow molding or the like from a material with little elasticity, such as a film material such as polyurethane or polyvinyl chloride. The balloon 3 has a length L of, for example, 130 mm or more and 180 mm or less, and expands into a cylindrical shape with an outer diameter D of 12 mm or more and 16 mm or less when inflated. When inflated, the balloon 3 becomes cylindrical and concentric with the central axis of the tube 2, except for the vicinity of the end 3a.

[0029] The outer diameter D and volume during inflation can be changed by controlling the amount of fluid injected into the internal space 3b of the balloon 3. For example, the amount of fluid Q discharged from the injection device may be calculated using the following formula (1). Thus, once the volume of the desired sleeve-shaped gastric tube is determined, the amount of fluid Q discharged from the injection device can be calculated. Q = Qa + Qb = kV + Qb (1) where Qa is the amount of fluid injected into the internal space 3b of the balloon 3 (= kV), V: volume of the intended sleeve-shaped gastric tube; k: coefficient, Qb: amount of fluid remaining in the passage from the injection device to the injection hole 21a which is the entrance of the balloon 3 k and Qb can be determined by actual measurement.

[0030] (How to use) Next, an example of a method of using the resection line guide device 1 will be described with reference to Fig. 5. Fig. 5 is a cross-sectional view of a stomach, which is a schematic diagram showing a state in which a balloon 3 is inflated inside the stomach.

[0031] (1) Insertion With the balloon 3 deflated so as to contact the tube 2, the tip 23 of the resection line guide device 1 is inserted transnasally to the vicinity of the pylorus 11 of the stomach 10. At this time, the position of the contrast medium-filled line 22 may be confirmed under X-ray fluoroscopy.

[0032] (2) Decompression of the stomach Next, the contents and air of the stomach 10 are sucked in by the suction device through the side hole 23c, the discharge passage 20 and the suction connection part 4, and the pressure inside the stomach 10 is reduced, causing the stomach 10 to become deflated.

[0033] (3) Balloon inflation Next, fluid is injected from the injection device through the fluid injection section 6, injection tube 5, fluid passage 21, and injection hole 21a into the internal space 3b of the balloon 3 to inflate the balloon 3. As the balloon 3 expands within the deflated stomach 10, the position of the balloon 3 can be grasped from outside the stomach 10 using laparoscopic images.

[0034] (4) Balloon positioning The stomach 10 is pulled with an endoscopic forceps 15 or the like, and the balloon 3 is positioned so as to be along the lesser curvature 12 side of the stomach 10 .

[0035] (5) Stomach resection Using the position (bulge) of the balloon 3 shown on the laparoscopic image as an index, the stomach 10 is cut along the resection line 14 with a suture instrument while pulling the greater curvature 13 side of the stomach 10 with an endoscopic forceps 15, and the greater curvature 13 side is extracted. The stomach 10 is also sutured during this resection. In this way, a sleeve-shaped stomach tube is formed.

[0036] (Effects of this embodiment) According to this embodiment, the following effects are obtained. (a) By expanding the balloon 3 into a cylindrical shape so as to follow the lesser curvature of the stomach, the amount of fluid injected into the internal space 3b of the balloon 3 is proportional to the volume of the desired sleeve-shaped gastric tube, and therefore, when performing sleeve gastrectomy, the resection line guide device 1 can be used as a guide for the volume of the stomach to be left. (b) It reduces intraoperative complications that may occur due to the insertion of a hard, thick tube into the stomach, and enables sleeve gastrectomy to be performed without the need for extensive equipment such as an endoscope. (c) Since the tube 2 is extremely thin, having a diameter of 4 mm or more and 6 mm or less, the resection line guide device 1 can be inserted transnasally into the stomach. (d) Even if a thin-diameter tube 2 is used, the cylindrical balloon 3 expands in the stomach to a length that matches the size of the stomach, allowing the resection line 14 to be clearly visualized under laparoscopy. (e) Since the contrast medium inclusion line 22 is provided in the tube 2, the position of the tube 2 can be confirmed under X-ray fluoroscopy.

[0037] (Variation 1) In the above embodiment, the inflated balloon 3 has a straight cylindrical shape, but may be curved to follow the lesser curvature. For example, the balloon 3 may be curved together with the tube 2 so that the inner circumferential surface thereof has a curved cylindrical shape with a radius of curvature of 50 mm or more and 200 mm or less when inflated. This makes it easier to make the balloon 3 follow the lesser curvature 12 of the stomach 10 compared to a configuration in which the balloon is inflated without being curved.

[0038] Although the embodiment of the present invention has been described above, the embodiment of the present invention is not limited to the above embodiment, and various modifications and implementations are possible.

[0039] In addition, some of the components of the above embodiment may be omitted or changed. For example, if the entry path of the resection line guide device 1 can be confirmed without using X-ray fluoroscopy, the contrast medium inclusion line 22 may not be provided. Also, the tube 2 may be formed from a material kneaded with a contrast medium without providing the contrast medium inclusion line 22. In addition, in the method of using the above embodiment, steps may be added, deleted, changed, replaced, etc. [Explanation of symbols]

[0040] 1...gastrectomy resection line guide device, 2...tube, 2a...tip side, 2b...base end side, 3...balloon, 3a...end portion, 3b...internal space, 4...suction connection portion, 5...Injection tube, 6...Fluid injection part, 10...Stomach, 11...Pylorus, 12...Lesser curvature, 13...Greater curvature, 14 ... resection line, 15 ... endoscopic forceps, 20 ... discharge passage, 21 ... fluid passage, 21a... injection hole, 22... contrast medium inclusion line, 22a... contrast medium, 23... tip portion, 23a... exposed portion, 23b... blocked portion, 23c... side hole, 23d... tip, 24…Scale

Claims

1. a flexible tube having a length sufficient to reach the pylorus of the stomach from the mouth or nose, and having a first passage and a second passage formed along a longitudinal direction; a balloon provided coaxially around the tube at the distal end side of the tube and capable of expanding into a cylindrical shape; a first hole communicating with the first passage formed at a tip portion of the tube exposed distally of the balloon; a first connection portion communicating with the first passage and to which a suction device is connected at a base end side of the tube; a second hole communicating with the internal space of the balloon and the second passage formed; and a second connection portion communicating with the second passage and to which an injection device for injecting fluid into the balloon is connected at a base end side of the tube.

2. The resection line guide device for gastrectomy according to claim 1 , wherein the balloon has a length of 130 mm or more and 180 mm or less.

3. 3. The resection line guide device for gastrectomy according to claim 1 or 2, wherein the balloon expands into a cylindrical shape having an outer diameter of 12 mm or more and 16 mm or less when the fluid is injected into the balloon.

4. 4. The resection line guide device for gastrectomy according to claim 1, wherein the balloon is formed, together with the tube, so that when inflated, the inner circumferential surface becomes a curved cylinder having a radius of curvature of 50 mm or more and 200 mm or less.

5. 5. The resection line guide device for gastrectomy according to claim 1, wherein the balloon is configured such that the amount of fluid injected therein is proportional to the volume of the target sleeve-shaped gastric tube.

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